Dosing of Carcinogenic Complexes After Anesthesia With Intrathecal Hyperbaric Prilocaine.

Anesthesia Clinical Trial

Official title:

Dosing of Carcinogenic Complexes Such as Urinary O-toluidine and Hemoglobin Adducts From O-toluidine in Blood After Intrathecal Administration of 50 mg Hyperbaric Prilocaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03642301
• Other study ID #: B076201836443
• Status: Completed
• Start date: January 10, 2019
• Est. completion date: March 27, 2019

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The prilocaine is a very common local anesthetic that has the disadvantage of being metabolized to o-toluidine, a human carcinogen.

Hyperbaric 2% prilocaine (HP), recently developped, is increasingly used for spinal anesthesia in ambulatory surgery. But the formation of carcinogenic metabolites induced by the hyperbaric prilocaine is not yet known. The aim of this study is to investigate whether the intrathecal administration of 50 mg hyperbaric prilocaine induces also the formation of carcinogenic complexes such as urinary o-toluidine and hemoglobin adducts from o-toluidine in blood.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 27, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age : > 18 years and < 80years

• American Society of Anesthesiology (ASA) score : I-II

• Height between 160cm and 180cm

Exclusion Criteria:

• Cardiac Disease (Aortic stenosis, heart failure...)

• coagulation disorder (International Normalized Ratio (INR) > 1.3; platelets <80 000/mm³)

• Allergic to local anesthetics

• Smoker

Related Conditions & MeSH terms

• Anesthesia

Locations

Country	Name	City	State
Belgium	Braine-l'Alleud Hospital	Braine-l'Alleud

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre	Hôpital de Braine-l'Alleud, Ruhr University of Bochum

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

Böhm F, Schmid D, Denzinger S, Wieland WF, Richter E. DNA adducts of ortho-toluidine in human bladder. Biomarkers. 2011 Mar;16(2):120-8. doi: 10.3109/1354750X.2010.534556. Epub 2010 Nov 30. Erratum in: Biomarkers. 2011 May;16(3):288. — View Citation

Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7. — View Citation

Gaber K, Harréus UA, Matthias C, Kleinsasser NH, Richter E. Hemoglobin adducts of the human bladder carcinogen o-toluidine after treatment with the local anesthetic prilocaine. Toxicology. 2007 Jan 5;229(1-2):157-64. Epub 2006 Oct 29. — View Citation

Gebhardt V, Herold A, Weiss C, Samakas A, Schmittner MD. Dosage finding for low-dose spinal anaesthesia using hyperbaric prilocaine in patients undergoing perianal outpatient surgery. Acta Anaesthesiol Scand. 2013 Feb;57(2):249-56. doi: 10.1111/aas.12031. Epub 2012 Nov 30. — View Citation

Guntz E, Latrech B, Tsiberidis C, Gouwy J, Kapessidou Y. ED50 and ED90 of intrathecal hyperbaric 2% prilocaine in ambulatory knee arthroscopy. Can J Anaesth. 2014 Sep;61(9):801-7. doi: 10.1007/s12630-014-0189-7. Epub 2014 Jun 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin adducts from o-toluidine in blood	Hemoglobin adducts from o-toluidine in blood is measured before surgery (at admission)	Time 0 (before surgery)
Primary	Hemoglobin adducts from o-toluidine in blood	Hemoglobin adducts from o-toluidine in blood is measured at 24 hours after intrathecal prilocaine injection	Time 24 hours after intrathecal prilocaine injection
Primary	Urinary o-toluidine	Urinary o-toluidine is measured before surgery (at admission)	Time 0 (before surgery)
Primary	Urinary o-toluidine	Urinary o-toluidine is measured at 6 hours after intrathecal prilocaine injection	Time 6 hours after intrathecal prilocaine injection
Primary	Urinary o-toluidine	Urinary o-toluidine is measured at 12 hours after intrathecal prilocaine injection	Time 12 hours after intrathecal prilocaine injection
Primary	Urinary o-toluidine	Urinary o-toluidine is measured at 24 hours after intrathecal prilocaine injection	Time 24 hours after intrathecal prilocaine injection